MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number	9-PDAP-05-04-L
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dyspnea (1816); Obstruction/Occlusion (2422)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The article, "left pulmonary artery occlusion following device closure of patent ductus arteriosus in premature infants", was reviewed.The article presented a case study of a 25-day-old, 975g, male patient with comorbidities persistent metabolic acidosis, ventilator dependence, twin died due to necrotizing enterocolitis (nec) with large patent ductus arteriosus (pda), bronchopulmonary dysplasia (bpd), and poor nutrition.It was reported on an unknown date a 5-4mm amplatzer piccolo occluder was chosen for implant to occluder a pda with the following dimensions: narrowest diameter = 3.3mm, largest diameter = 4.3mm, and length = 12mm.It was reported 12 weeks post-procedure, transthoracic echocardiography showed an increase in maximal gradient velocity with minimal flow by color doppler.The patient additionally required respiratory support.An angiography revealed severe obstruction to the lpa.A decision was made to attempt percutaneous revascularization of the lpa but unsuccessful.The patient was then admitted for surgical revascularization of the lpa and the proximal disc of the 5-4mm amplatzer piccolo occluder was excised to relieve the obstruction.The patient status was reported discharged with excellent lpa flow and only mild turbulence at 3 month follow up.The article concluded although rare, severe lpa obstruction can be seen in premature infants following device closure of the pda.The piccolo device is designed to ideally remain entirely intraductal.Although device selection appeared to provide a device short enough for the given ductal length, they recommend, whenever possible, giving consideration to using the shortest possible device.We also recommend increasing the frequency of echocardiographic surveillance to weekly studies if at any time the imaging demonstrates an increase in the degree of obstruction/turbulence.Clinicians should have a low threshold for alternative imaging modalities such as computed tomography or more invasive options if a pattern of increased obstruction is detected.This may allow for a transcatheter based intervention to either retrieve the device, if relatively soon, or stent the lpa, if patient size allows.[the primary and corresponding author was jesus jaile, children¿s hospital of new orleans / lsuhsc, new orleans, louisiana, with corresponding email: jesus.Jaile@lcmchealth.Org].
Additional Manufacturer Narrative
Summarized patient outcomes/complications of amplatzer piccolo were reported in a research article in a subject population with multiple co-morbidities including persistent metabolic acidosis, ventilator dependence, twin died due to necrotizing enterocolitis (nec) with large patent ductus arteriosus (pda), bronchopulmonary dysplasia (bpd), and poor nutrition.Some of the complications reported were unexpected medical intervention, surgical intervention, hospitalization, obstruction/occlusion, and dyspnea.; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.  per the instructions for use, it stated, " warnings: do not release the occluder from the delivery wire if either a retention disc protrudes into the pulmonary artery or aorta; or if the position of the occluder is not stable." this is considered as an improper or incorrect procedure or method of the device.However, it was unable to determine if an improper or incorrect procedure or method contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.
Event or Problem Description
The article, "left pulmonary artery occlusion following device closure of patent ductus arteriosus in premature infants", was reviewed.The article presented a case study of a 25-day-old, 975g, male patient with comorbidities persistent metabolic acidosis, ventilator dependence, twin died due to necrotizing enterocolitis (nec) with large patent ductus arteriosus (pda), bronchopulmonary dysplasia (bpd), and poor nutrition.It was reported on an unknown date a 5-4mm amplatzer piccolo occluder was chosen for implant to occluder a pda with the following dimensions: narrowest diameter = 3.3mm, largest diameter = 4.3mm, and length = 12mm.During procedure, it was reported device implant was straightforward, and post release transthoracic echocardiography (tte) showed it to be well seated with only slight left pulmonary artery (lpa) turbulence caused by the proximal disc.It was then reported 12 weeks post-procedure, tte showed an increase in maximal gradient velocity with minimal flow by color doppler.The patient additionally required respiratory support.An angiography revealed severe obstruction to the lpa caused by the proximal disc.A decision was made to attempt percutaneous revascularization of the lpa but unsuccessful.The patient was then admitted for surgical revascularization of the lpa and the proximal disc of the 5-4mm amplatzer piccolo occluder was excised to relieve the obstruction.The patient status was reported discharged with excellent lpa flow and only mild turbulence at 3 month follow up.The article concluded although rare, severe lpa obstruction can be seen in premature infants following device closure of the pda.The piccolo device is designed to ideally remain entirely intraductal.Although device selection appeared to provide a device short enough for the given ductal length, they recommend, whenever possible, giving consideration to using the shortest possible device.We also recommend increasing the frequency of echocardiographic surveillance to weekly studies if at any time the imaging demonstrates an increase in the degree of obstruction/turbulence.Clinicians should have a low threshold for alternative imaging modalities such as computed tomography or more invasive options if a pattern of increased obstruction is detected.This may allow for a transcatheter based intervention to either retrieve the device, if relatively soon, or stent the lpa, if patient size allows.[the primary and corresponding author was (b)(6), with corresponding email: (b)(6).

• Brand Name: AMPLATZER PICCOLO
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18104423
• Report Number: 2135147-2023-04947
• Device Sequence Number: 5556127
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-05-04-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 25 DA
• Patient Sex: Male